An On-track Trial to Assess Driving from Medical Cannabis

The CAN-TRACK trial is a closed-circuit track study designed to assess the effects of medical cannabis on driving performance, focusing on cognitive and behavioural outcomes among patients currently prescribed medical cannabis for managing chronic pain, anxiety, or sleep disorders. Participants must be on a stable dose of at least 2 mg THC per dose for a minimum of 3 months. Medical cannabis will be administered as prescribed (oral or inhaled), under the supervision of the research team during the study sessions. The intervention will be delivered face-to-face, individually, at two testing sites: the Australian Automotive Research Centre (AARC) and Metropolitan Traffic Education Centre (METEC). This semi-naturalistic baseline-controlled study will assess real-world driving performance in 72 patients who are prescribed THC-containing medical cannabis. Patients will be stratified based on their health condition (chronic pain, anxiety, or sleep disorder) and the primary route of administration (oral or inhaled products). Patients will undergo repeated driving assessments on three separate days, with additional biological and impairment assessments conducted before and after consuming their prescribed cannabis product. The study schedule is detailed below- (0) Screening session: Eligibility criteria assessed by a registered research nurse at Swinburne University of Technology. This screening session will last approximately 1-hour. (1) Baseline session at AARC: A practice drive will be completed 15 minutes prior to baseline. Baseline driving performance will be assessed at least 12-hours following last medical cannabis self-administration and approximately 20-hours prior to administering the next dose. This session will last approximately 2 hours and will occur on Day 1 (i.e., Monday). (2) Morning after/post-administration session at AARC: For patients with inhaled medical cannabis prescriptions, driving performance will be assessed at T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose). For patients with orally consumed medical cannabis prescriptions, driving performance will be assessed continuously at T1 (pre-dose), T2 (1.5-hours post-dose), and (3.5-hours post-dose). This session will last approximately 7 hours and will occur on Day 2 (i.e., Tuesday). (3) Next day/post-administration session at METEC: For patients with inhaled medical cannabis prescriptions, driving performance will be assessed continuously at T1 (pre-dose), T2 (0.5-hours post-dose), and T3 (2.5-hours post-dose). For patients with orally consumed medical cannabis prescriptions, driving performance will be assessed continuously at T1 (pre-dose), T2 (1.5-hours post-dose), and T3 (3.5-hours post-dose). This session will last approximately 7 hours and will occur on Day 5 (i.e., Friday). The entire study duration for each participant is approximately two weeks (inclusive of screening a week prior). Adherence to the intervention will be closely monitored, with researchers supervising the administration of medical cannabis during the study sessions.